Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

Supernus Pharmaceuticals, Inc.78 enrolled

Overview

The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.

This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male or female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD with persistent serious conduct problems. To determine eligibility for the study, subjects will undergo an initial screening visit. Seventy-two subjects will be randomized in the study; assuming a 17% dropout rate, it is anticipated that 60 subjects will complete the study. The study will consist of a Screening Period (within 28 days prior to the first dose administration), a Titration Period of 2 to 5 weeks, a Maintenance Period of 6 weeks, and a Safety Follow-up, which will be performed 30 days after the final study visit. The total subject duration in the study will be 16 to 19 weeks depending on the treatment group assignment. The total study duration is anticipated to be 15.5 months. A total of 72 subjects will be randomized based on weight at baseline, to 1 of 4 treatment groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Attention Deficit Disorder With Hyperactivity Conduct Disorder

Interventions

SPN-810DRUG

1.67mg capsule taken TID

SPN-810DRUG

3.33mg capsule taken TID

SPN-810DRUG

5mg capsule taken TID

SPN-810

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy pediatric male or female subjects, age 6 to 12 years. 2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD. 3. NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people. 4. IQ greater than 71. Exclusion Criteria: 1. Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified. 2. Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder. 3. Any other anxiety disorder as primary diagnosis. 4. Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline. 5. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.

Locations (9)

Florida Clinical Research Center

Bradenton, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

CNS Healthcare

Orlando, Florida, United States

Capstone Clinical Research

Outcomes

Primary Outcomes

The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score

The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a "0" and the highest score is "198". A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).

Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Secondary Outcomes

The Changes From Baseline in the CGI-S

The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subject's global functioning prior to and after the administration of study medication. The severity of illness (CGI-S) is rated by the investigator on a 7-point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). A lower overall score in subsequent testing indicates successful therapy.

Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)

Clinical Global Impression - Improvement Scale (CGI-I)

Clinical Global Impression Scale. CGI-I is measured relative to the condition at the Baseline on a 7-point scale with 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A lower overall score in subsequential testing indicates successful treatment. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).

Data from ClinicalTrials.gov

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